Danaher Corporation Sr. MES Engineer in Muskegon, Michigan
Be part of something altogether life-changing!
Working at Cytiva in the Life Sciences industry means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40 countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.
Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
What you’ll do
The MES Engineer at Cytiva’s new plant at Muskegon, Michigan will be critical for the start-up and manufacturing of Cytiva’s resins plant. Initially Reporting to the Interim Operations Lead, the MES Engineer will be part of the start-up of Operations.
The role will at first have a focus on project activities and collaboration with the existing resins site in Uppsala, Sweden. This MES Engineer position will be part of a Multisite, System Support and Development team. The SS&D team is purposed to deliver and support Manufacturing Execution Systems through championing standardization of business processes and common PAS-X (Software by Körber) modules that enable manufacturing sites to deliver world class performance.
Play a key role in the implementation of the Manufacturing Execution System.
Active part in the ongoing project to setup a manufacturing plant in Muskegon with MES focus. Eg lead workshops and gather user requirements.
Configure & deploy MES software application and system.
Designing, building, testing and documenting of MES.
Responsible for the development and adherence of MES governance procedures.
Working with the MES vendor and System Integrator to ensure that systems are being delivered to specification and schedule.
Provide organisation oversight for complex systems involving the development of MES, especially interfacing with equipment and Manufacturing Information Systems, e.g. data historians, ERP, HMIs etc.
Managing PAS-X software release lifecycle, licensing technology & processes.
Support daily operation and future enhancements of MES and lower-level systems as technical expert.
Drive new releases & hot fixes technical assessments and related interoperability test with PAS-X.
Managing application regression testing.
Provide support for operationalizing the manufacturing and peripheral systems.
Enable common processes across manufacturing sites.
Proactively influence the business towards replication & standardization to drive value and implement the appropriate technical solutions.
Be part of the validation process for MES and other OT systems.
Develops/assists in the creation and maintenance of the interfaces with external systems.
Gather user requirements in relation to controlling and recording manufacturing activities.
Ensure a robust cybersecurity approach to IT and OT systems working with the IT and OT team.
Who you are
Minimum bachelor's degree in an engineering discipline.
Experience with MES, preferably Körber (Werum) PAS-X, in a bio-tech, chemical, or process manufacturing environment.
Must have 3 plus years of hands-on experience in biotech manufacturing or similar.
IT/OT infrastructure experience highly desirable.
Have prior experience working on a project team to implement, customize, or enhance an MES system.
Understanding of supply chain, manufacturing domains and supporting technology including manufacturing and supply chain ERP systems (e.g. Oracle, SAP).
Integration of Emerson Delta V and/or ABB 800xA experience is highly desirable.
Integration of 3rd party OEM vendor equipment experience is an advantage.
Sound understanding of Electronic Batch Records (EBR) and Review by Exception (RBE).
Knowledge of ISA95 Architecture Model and S88 standards and terminologies.
General awareness and knowledge of security, regulatory, legal, and quality requirements (privacy & GxP).
Knowledge of industry standard integration protocols and programming applications such as OPC, ODBC and SQL.
Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices.
Familiarity with Business Intelligence (BI) and reporting programs including Crystal Reports or similar tools.
Understanding of computer system validation.
Strong technical and problem-solving skills and the ability to work independently.
Strong interpersonal skills, especially regarding, teamwork and collaboration.
Ability to effectively communicate with both technical and non-technical team members.
Willingness to travel in the initial project phase.
Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing. LIMS experience is an advantage.
Demonstrated success working in a high-performing, business results-driven environment.
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at firstname.lastname@example.org to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.